# K110819: Singhmed Roolip Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: J.Singh Instruments
- Decided: Oct 5, 2011 after 196 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954311 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954311: Koh Colpotomizer System, CooperSurgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K161065: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (2016), 0 descendants of its own

## Indications for use
The Singh Colpotomizer System is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required. The surgeon makes the colpotomy incisions to access or remove intraperitoneal tissue.

Source page: https://510kreport.com/device/K110819
Methodology: https://510kreport.com/methodology